A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer (ENSPIRIT)

April 7, 2026 updated by: Achieve Life Sciences

A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

The primary objective of the study is to compare overall survival of participants randomized to receiving custirsen in combination with docetaxel with participants randomized to receive docetaxel alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

664

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Heidelberg, Australia
        • Austin Health
      • Hobart, Australia
        • Royal Hobart Hospital
      • Kogarah, Australia
        • St George Hospital
      • Malvern, Australia
        • Cabrini Hospital Malvern
      • Port Macquarie, Australia
        • Port Macquarie Base Hospital
      • Toorak Gardens, Australia
        • Burnside War Memorial Hospital
    • Victoria
      • Wodonga, Victoria, Australia
        • Border Medical Oncology
  • Germany
      • Cologne, Germany
        • Kliniken der Stadt Koln gGmbH
      • Gauting, Germany
        • Asklepios Fachkliniken GmbH
      • Halle, Germany
        • Krankenhaus Martha Maria Halle Dölau gGmbH
      • Hamburg, Germany
        • Kath. Marienkrankenhaus gGmbH
      • Kassel, Germany
        • Klinikum Kassel
  • Hungary
      • Budapest, Hungary
        • Uzsoki Utcai Kórház
      • Budapest, Hungary
        • Országos Korányi Pulmonológiai Intézet
      • Szolnok, Hungary
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet
  • Israel
      • Jerusalem, Israel
        • Hadassah University Hospital Ein Kerem
      • Kfar Saba, Israel
        • Meir Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Yizre‘el, Israel
        • Assaf Harofe Medical Center
  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
      • Bergamo, Italy
        • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
      • Genova, Italy
        • Istituto Nazionale per la Ricerca sul Cancro
      • Livorno, Italy
        • Ospedale Livorno
      • Lombardia, Italy
        • ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
      • Milan, Italy
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
      • Milan, Italy
        • ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo di Pavia
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Palmerston North, New Zealand
        • Palmerston North Hospital
      • Tauranga, New Zealand
        • Tauranga Hospital
  • Poland
      • Olsztyn, Poland
        • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
      • Poznan, Poland
        • Med-Polonia Sp. z o.o.
  • Russia
      • Arkhangelsk, Russia
        • Arkhangelsk Regional Clinical Oncology Dispensary
      • Obninsk, Russia
        • Federal State Institution Medical Radiology Research Center
      • Saint Petersburg, Russia
        • Leningrad Regional Clinical Hospital
      • Sochi, Russia
        • Oncology Centre #2
      • Yaroslavl, Russia
        • Regional Clinical Oncology Hospital
  • South Korea
      • Busan, South Korea
        • Kosin University Gospel Hospital
      • Incheon, South Korea
        • Gachon University Gil Hospital
      • Seongnam, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, South Korea
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Samsung Medical Center - PPDS
  • Spain
      • Alcorcón, Spain
        • Hospital Universitario Fundación Alcorcón
      • Barcelona, Spain
        • Hospital del Mar
      • Las Palmas de Gran Canaria, Spain
        • Complejo Hospitalario Universitario Insular-Materno Infantil
      • Las Palmas de Gran Canaria, Spain
        • Consorcio Hospitalario Provincial de Castellon
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Majadahonda-Madrid, Spain
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Sabadell, Spain
        • Corporacio Sanitaria Parc Tauli
      • Valencia, Spain
        • Hospital Universitario Doctor Peset
  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
  • Thailand
      • Hat Yai, Songkhla, Thailand
        • Songklanagarind Hospital Prince of Songkla University
      • Phayathai, Bangkok, Thailand
        • National Cancer Institute
      • Phisanulok, Thailand
        • Buddhachinnaraj Hospital
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Municipal institution Multifield City Clinical Hospital Numero 4 of Dnipropetrovsk Regional Council
      • Kharkiv, Ukraine
        • Municipal Noncommercial Institution Regional Center of Oncology
      • Lutsk, Ukraine
        • Treatment and Prevention Institution Volyn Regional Oncology Dispensary
      • Simferopol, Ukraine
        • Treatment and Diagnostics center of LLC Center of Clinical Diagnostics
      • Sumy, Ukraine
        • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
      • Uzhhorod, Ukraine
        • Central City Clinical Hospital
      • Vinnytsia, Ukraine
        • Vinnytsya Regional Clinical Oncology Dispensary
  • United States
    • Florida
      • Boynton Beach, Florida, United States
        • University Cancer Institute
      • Orlando, Florida, United States
        • Florida Hospital
    • Georgia
      • Athens, Georgia, United States
        • University Cancer and Blood Center, LLC
    • Illinois
      • Joliet, Illinois, United States
        • Joliet Oncology-Hematology Associates Ltd.
    • Kentucky
      • Hazard, Kentucky, United States, 33426
        • Kentucky Cancer Clinic
    • Missouri
      • St Louis, Missouri, United States
        • Missouri Baptist Cancer Center
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Novant Health
    • Ohio
      • Akron, Ohio, United States
        • Summa Health System
      • Canton, Ohio, United States
        • Aultman Hospital
    • Tennessee
      • Knoxville, Tennessee, United States
        • Center for Biomedical Research LLC
      • Nashville, Tennessee, United States
        • Sarah Cannon Cancer Center
    • Texas
      • Tyler, Texas, United States
        • Blood and Cancer Center of East Texas
      • Tyler, Texas, United States
        • Tyler Hematology/Oncology PA
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists (Leesburg) - USOR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IV per American Joint Committee on Cancer 7th edition Tumor size, lymph Nodes affected, Metastases staging) non-small cell lung cancer (NSCLC).
  2. Males or females ≥ 18 years of age at screening.
  3. Life expectancy of > 12 weeks from screening, according to the investigator's assessment.
  4. Patients must have received one prior line of platinum-based systemic anticancer therapy for advanced or metastatic NSCLC. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued at the end of a treatment regimen.
  5. Patients must have documented radiological disease progression either during or after the first-line therapy.
  6. Patients must have at least one measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.

  8. Have adequate values, bone marrow, renal and liver functions at screening as defined below:

    • Absolute neutrophil count ≥ 1.5 x 10^9/L
    • Platelet count ≥ 100 x 10^9/L
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    • Total Bilirubin ≤ 1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert's disease)
    • Aspartate aminotransferase and alanine aminotransferase ≤ 1.5 x ULN.
  9. Resolution of any toxic effects of prior therapy to Grade ≤1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (exception of alopecia and ≤ Grade 2 peripheral neuropathy).
  10. Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization.
  11. Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the chemotherapy/custirsen last dose. Men of reproductive potential who are not surgically sterile must agree to abstain from sexual activity or use medically accepted and highly effective method of contraception during and for 6 months after the chemotherapy/custirsen last dose.
  12. Patients must be willing and able to give written informed consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study.

Exclusion Criteria:

  1. Patients treated with any systemic anti-cancer therapy for NSCLC within 21 days prior to randomization (6 weeks for bevacizumab).
  2. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
  3. Major surgical procedure within 4 weeks prior to randomization. Patient must have recovered from all surgery-related complications.
  4. Patients with known central nervous system (CNS) metastases (patients with any clinical signs of CNS metastases must have a computed tomography or magnetic resonance imaging of the brain to rule out CNS metastases in order to be eligible for participation in the study). Patients who have had brain metastases treated with radiotherapy or surgically removed with no residual disease confirmed by imaging; patients should be clinically stable and off corticosteroid treatment at least 3 weeks prior to randomization).
  5. Patients with current diagnosis or a history of another active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 5 years previously with no evidence of recurrence).
  6. Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (≥ Grade 2, according to NCI CTCAE v4.0) or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
  7. A history of events such as myocardial infarction, cerebrovascular accident or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
  8. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
  9. Female patients who are breastfeeding.
  10. Patients previously treated with docetaxel for NSCLC or with known severe hypersensitivity to taxane therapies.
  11. Patients with known and documented epidermal growth factor receptor (EGFR) mutation who have not received an EGFR inhibitor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Custirsen + Docetaxel

Custirsen: Three loading doses of custirsen 640 mg intravenously (IV) over 2 hours administered in 5 to 9 days prior to Day 1 of Cycle 1, then custirsen 640 mg IV weekly every 21-day cycle. Docetaxel: 75 mg/m^2 IV over 1 hour on Day 1 of every 21-day cycle.

Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or protocol-specified parameters to stop.
Drug: Docetaxel
Drug: Custirsen
Other Names:
  • OGX-011
  • TV-1011
Active Comparator: Docetaxel

Docetaxel: 75 mg/m^2 IV over 1 hour on Day 1 of every 21-day cycle.

Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or protocol-specified parameters to stop.
Drug: Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival: All Randomized Population
Time Frame: From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)
Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.
From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)
Overall Survival: Stratified by Histology - Squamous vs. Non-Squamous
Time Frame: From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)
Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.
From randomization to death or last known date alive (up to 1331 days for Docetaxel arm and up to 1271 days for Docetaxel + Custirsen arm)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival per RECIST v1.1
Time Frame: 60 months
Progression Free Survival: time from date of randomization to first objective documented progression per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Tumor lesions measured in at least one dimension with minimum size of 10 mm by CT scan, 10 mm caliper by clinical exam. Malignant lymph nodes must be >15 mm in short axis when assessed by CT scan. All measurable lesions up to a maximum of 2 lesions per organ and 5 in total representative of all involved organs should be identified as target lesions and measured and recorded.
60 months
Objective Response Rate as defined by RECIST v1.1.
Time Frame: 60 months
Objective Response (OR) is defined as achieving a best overall response of complete response (CR) or partial response (PR), as defined using RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
60 months
Duration of Disease Control
Time Frame: 60 months
The Duration of Disease Control is defined as the time from randomization to the date of the first documented disease progression (taking as reference for progressive disease the smallest measurements recorded on study) or death, whichever occurs first.
60 months
Adverse events
Time Frame: 60 months
Adverse events and concomitant medications will be collected throughout the study up to 28 days after the last dose of study treatment. Medical history will be assessed, mutation status will be collected, if available, and an electrocardiogram will be performed at screening. Physical examination, vital signs, and laboratory evaluations will be conducted at screening and throughout the study.
60 months
Duration of Objective Response
Time Frame: 60 months
The evaluation of overall response at each assessment is a composite of target lesion response, non-target lesion response, presence of new lesions.
60 months
Disease Control Rate
Time Frame: 60 months
The disease control rate will be calculated as the total number of patients in each group with best overall response of CR, PR or Stable Disease (SD) divided by the total number of randomized patients in the group and will be compared similarly as Objective Response Rate (ORR.)
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Achieve Life Sciences

Investigators

  • Principal Investigator: Joachim Von Pawel, MD, Asklepios Fachkliniken GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2012

Primary Completion (Actual)

November 17, 2016

Study Completion (Actual)

November 17, 2016

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimated)

June 28, 2012

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV1011-LC-303
  • 2012-002447-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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